# FDA 483 - Pemco Inc - December 16, 2021

Source: https://www.globalkeysolutions.net/records/483/pemco-inc/64e9619a-8825-429a-bff1-7e9f3e2cab34

> FDA 483 for Pemco Inc on December 16, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pemco Inc
- Inspection Date: 2021-12-16
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Pemco Inc., a medical device manufacturer in Independence, OH, revealed significant deficiencies across multiple quality system areas. The firm failed to validate critical cleaning processes, maintain adequate document and design controls, properly manage customer complaints from service returns, and establish sufficient supplier quality requirements. These issues indicate a moderate level of non-compliance with medical device quality system regulations.

## Related Officers

- [Brian M Marosan](https://www.globalkeysolutions.net/people/brian-m-marosan/7954e296-d16b-4a87-b773-038732777bb8)
- [Investigator ](https://www.globalkeysolutions.net/people/benjamin-j-dastoli/688c2ad7-f7ac-47eb-8ca2-4efcd221f636)

Company: https://www.globalkeysolutions.net/companies/pemco-inc/83baa591-16b5-4a52-be13-f961caee69e8

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22